BERLIN, Dec 5 (APM) - German drugs regulator BfArM has started suspending sales of generics whose approvals were based on studies by Indian contract research organisation GVK Biosciences, following allegations the firm had systematically falsified study results, the regulator said on Friday.
The suspension means the drugs may not be sold until the pharmas who contracted GVK Biosciences submit new studies proving their products are bioequivalent to the originator drugs.
Generics whose bioequivalency was tested by the GVK, and were nationally approved between 2008 and 2014 are affected by the suspension, said the BfArM in a statement.
As previously reported, France's ANSM discovered severe deficiencies in GVK's conduct of studies and the validity of its data (APMMA 40699).
Due to the severity and the systematic nature of the deficiencies, the BfArM views the bioequivalency studies as unacceptable as a basis for approval, for safety-related reasons although there is no evidence of danger to patients, the regulator said.
BfArM is examining 176 drugs from 28 pharmas, none of whom have been named. The Süddeutsche Zeitung however previously mentioned Hexal and Betapharm, who have three drugs under review between them.
The European Medicines Agency is also examining further drug approvals for possible deficiencies, alongside the German regulator's efforts, BfArM said.
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